Glossary / I

Glossary: I

81 terms.

• IATA DGR
• ICH E6(R3) Good Clinical Practice
• ICH M7ICH M7(R2) DNA-Reactive (Mutagenic) Impurities
• ICH Q10ICH Q10 — Pharmaceutical Quality System
• ICH Q11
• ICH Q12Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
• ICH Q13Continuous Manufacturing of Drug Substances and Drug Products
• ICH Q14
• ICH Q1AICH Q1A(R2) Stability Testing of New Drug Substances and Products
• ICH Q1A Stability Storage Conditions
• ICH Q2Validation of Analytical Procedures
• ICH Q3A Impurities Drug Substance
• ICH Q3A/BICH Q3A(R2) / Q3B(R2) — Impurities in New Drug Substances / Products
• ICH Q3B Impurities Drug Product
• ICH Q3DICH Q3D(R2) Elemental Impurities
• ICH Q5AICH Q5A(R2) — Viral Safety Evaluation of Biotechnology Products
• ICH Q6Specifications: Test Procedures and Acceptance Criteria
• ICH Q7ICH Q7 — GMP for Active Pharmaceutical Ingredients
• ICH Q9ICH Q9 — Quality Risk Management
• ICH Q9(R1)
• ICH stability zones (IVb hot-humid)
• ICP-MS heavy metals (USP <2232>)
• Identity Testing (21 CFR 111.75)
• IEC 60601Medical electrical equipment — General requirements for basic safety and essential performance
• IEC 62304Medical device software — Software life cycle processes
• IEC 62366Medical devices — Application of usability engineering
• IEC 62366-1
• IEC 82304IEC 82304-1 — Health Software Product Safety
• IFDA (Iran)
• IFUInstruction For Use
• IMDG (Sea Transport)
• IMDG Code
• IMDRF Essential Principles
• Impeller and Chopper Speed
• IMSInterstate Milk Shippers
• In Spec / Out of Spec
• In-Process Check
• In-Process Quality Gate
• In-Process Reconciliation
• In-process specs & reconciliation (21 CFR 111.110)
• Inbound Receiving
• Incoming Inspection
• Incoterms 2020
• Incubation Step Log
• Infinite Capacity Scheduling
• Ingredient Add Verification
• Inlet Air Temperature (Coating)
• Installation Qualification (IQ)Installation Qualification
• Interleaved Tasks (Put-Away ↔ Pick)
• Interlock Logic
• Inventory Accuracy
• Inventory Shrinkage
• Inventory Turns
• INVIMA (Colombia)
• IPCIn-Process Control
• IPVIn-Process Verification
• IQ / OQ / PQInstallation / Operational / Performance Qualification
• IQ/OQ/PQ Workflow
• ISA 88 Physical ModelInternational Society of Automation (ISA) Standard 88 Physical Model
• ISA 88 Procedural Model
• ISA-88ANSI/ISA-88 — Batch Control
• ISA-88 Recipe Management
• ISA-95ANSI/ISA-95 — Enterprise-Control System Integration
• ISA-95 Level 3International Society of Automation (ISA) 95 — Level 3 (Manufacturing Operations Management)
• ISA-95 Level 4
• ISBT 128International Society of Blood Transfusion — Standard 128
• ISO 10993Biological evaluation of medical devices
• ISO 13485
• ISO 13485 Amendment Review
• ISO 14155:2020 — Clinical investigation of medical devices
• ISO 14971Medical devices — Application of risk management
• ISO 14971:2019 Benefit-Risk Documentation
• ISO 22400ISO 22400 — KPIs for Manufacturing Operations Management
• ISO 8655Piston-operated volumetric apparatus
• ISO 9001
• ISO audit
• ISO/IEC 27001:2022
• ISP (Chile)
• IVDIn Vitro Diagnostic device
• IVDREU In Vitro Diagnostic Regulation (2017/746)
• IVDR Transition Extension (2024)